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Cole Werble is the former owner and editorial director of FDC Reports, Inc., the publisher of The Pink Sheet, The Gray Sheet, and other leading news publications for the health care industry. He has more than 35 years of experience analyzing business critical developments affecting the biopharma sector and developing world class information products for the sector.
A core group of big pharma companies has been pressing FDA for over a decade to adopt a quantitative formula for conducting and communicating benefit-risk decisions. FDA has changed its benefit-risk calculations in response – but not its basic way of doing the math.
Illustrating that principles articulated in 2012 draft are being broadly accepted at FDA, final guidance on enrichment strategies for clinical trials adds new examples from across the agency’s drug review divisions.
Gilead faces two-pronged policy challenge in its core HIV business: its Part D product line could lose protections, but prophylactic prescriptions could dramatically expand under the Trump Administration's plan to eliminate HIV transmission.
Search for solutions to chronic drug shortages may require policymakers to push for payment policies that run counter to the current drug pricing themes, like retrofitting US Medicare’s New Technology Add-On Payments to apply to old, off-patent therapies.